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NCT07874178
Temporal Interference Stimulation for Disorders of Consciousness
Conditions: Disorder of Consciousness, Minimally Conscious State, Vegetative State, Unresponsive Wakefulness Syndrome, Brain Injury
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 4
Sponsor: Centre Hospitalier Universitaire de Liege
Summary
This study aims to investigate whether a new non-invasive brain stimulation technique, called temporal interference stimulation, can influence brain activity and potentially improve signs of consciousness in patients with severe brain injuries and disorders of consciousness.
After a severe brain injury, some patients may remain unable to communicate or interact normally with their environment because of impaired consciousness. Current treatment options to promote recovery are limited. Temporal interference stimulation is a new technique that uses mild electrical currents applied through electrodes placed on the scalp to target specific areas deep inside the brain without surgery.
In this study, we will use brain imaging data to personalize the stimulation and target a region involved in consciousness regulation, called the thalamus. The effects of the stimulation will be evaluated using brain activity recordings, heart monitoring, and clinical assessments of consciousness and responses to stimulation.
The goal of this research is to determine whether temporal interference stimulation is safe and whether it can produce measurable changes in brain function and behavior in patients with disorders of consciousness. The results may help guide future research on new treatments for recovery after severe brain injury.
Eligibility Criteria
Inclusion Criteria:
* Age ≥18 years.
* Diagnosis of unresponsive wakefulness syndrome or minimally conscious state confirmed by at least two Coma Recovery Scale-Revised (CRS-R) assessments.
* More than 28 days after the brain injury.
* Acquired brain injury of known etiology, including: Traumatic brain injury; Isolated intracranial hemorrhage (including subarachnoid, subdural, epidural, intracerebral, or iatrogenic hemorrhage); Stroke of any etiology; Cerebral anoxia/hypoxia (e.g., following cardiac arrest, drowning, choking, or drug overdose); Other acquired brain injuries (e.g., infectious encephalitis, carbon monoxide poisoning, or chemical/solvent inhalation).
* Available structural brain MRI.
* Medically stable.
* Written informed consent provided by the participant's legally authorized representative.
Exclusion Criteria:
* History of neurological or psychiatric disorder prior to the brain injury.
* Pregnancy (excluded based on medical records or a pregnancy test, if applicable).
* Presence of active brain implants and/or intracranial metallic implants.
* Uncontrolled epilepsy
Source: ClinicalTrials.gov (NCT07874178). StuddyBuddy aggregates publicly available trial information.